This goal of this application is to establish a Biomarker Validation laboratory (BVL) at the University of Alabama at Birmingham, which will provide both the expertise and sufficient quantities of high quality resources to act as an efficient referral center within the Early Detection Research Network (EDRN) of the NCI. The P.I. Investigator, William B. Grizzle, MD, PhD, has assembled a group of investigators with expertise in biomarker evaluation and with a commitment to translational research. The UAB-BVL will offer a broad range of validation systems, as indicated in the RFA, and clinical and research expertise in tumors of various organ systems, including breast, prostate, colorecturn, lung, head and neck, and gynecologic. The major focus of the UAB-BVL will fulfill the requests for the development of well-characterized tissue resources, including urine and serum, that have been collected and stored according to standard procedures; the development of high through-put immunohistochemical techniques that have been characterized according to specificity, sensitivity, and reproducibility; and the molecular characterization of lesions that are currently defined histologically or morphologically. A Development Proposal entitled Molecular Markers to Characterize Aggressive PIN lesions addresses the issue of molecular characterization of PIN lesions in prostate cancer using tissue matrix technology. The BVL leverages the considerable expertise of the investigators and will provide access to established tissue resources, standard operating procedures, and quality control systems as well as equipment. The Core Facilities of the UAB Comprehensive Cancer Center together with other Centers of Excellence at UAB further enhances the available resources. The existing collaborations among the investigators at UAB and the associated institutions and prior participation in national networks (CHTN, EDRN) will ensure rapid and effective responses to the needs of the EDRN. An organizational structure has been developed that defines lines of authority and communication to ensure both high quality performance and effective and timely communication. The research objectives of all of the investigators in this proposal match those of the EDRN: to rapidly translate basic research findings into a full understanding of the pathogenesis of neoplasia such that cancer patients can benefit from early detection, improved prognostic tools, and rapid development of more effective therapeutic and preventive strategies through the use of surrogate end- point markers.